Health TrialsbyHealthPanel

Hypersomnia in the Paediatric Population

ConditionsWakefulness DisorderNarcolepsyIdiopathic Hypersomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity Hospital, Montpellier

About this trial

This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included:

Group A: children from the general population with no complaints of sleepiness; Group B: children with a sleep disorder or excessive sleepiness associated with a medical condition (narcolepsy, circadian rhythm sleep disorder (CRSD), non-REM parasomnias, attention deficit disorder with or without hyperactivity (ADHD), autism spectrum disorder (ASD) or obesity); Group C: healthy volunteers with no medical conditions or sleep-related complaints.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be aged between 6 and 17 (< 18 years old).

Be able to express consent to participate.

Have at least one legal guardian.

Speak and understand French.

Disqualifiers

Souhait du mineur d'interrompre l'étude.

Maladie ou condition intercurrente qui interfère avec la poursuite de la participation du sujet à l'étude.

Lors de la visite 2 : si traitement médicamenteux qui agit sur la somnolence ou la vigilance, ou qui n'a pas été stoppé suffisamment tôt.

Décision de l'investigateur.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleepness and wakeness scale

    Other intervention

    Pediatric Hypersomnia Survey (PHS) Pediatric Daytime Sleepiness Scale (PDSS) Somnolence Scale Adapted for Children and Adolescents French Sleepiness Scale for Children Idiopathic Hypersomnia Severity Scale µMunich Short Chronotype Questionnaire

  • Polysomnography

    Procedure/Surgery

    Polysomnography over 24 hours

  • Actimetry

    Procedure/Surgery

    Actimetry over 2 weeks

  • Diagnostic scales

    Other intervention

    Pediatric Narcolepsy Severity Scale Insomnia Severity Index Children's Depression Inventory Epworth Sleepiness Scale for Children and Adolescents Life Experiences and Perceived Health among Adolescents Pure Procrastination Scale Sleep Disturbance Scale for Children

  • Ambulatory blood pressure monitoring (ABPM)

    Procedure/Surgery

    Ambulatory blood pressure monitoring (ABPM) over 24 hours

  • blood sampling

    Other intervention

    10 mL of blood are taken

  • Urine collection

    Other intervention

    Urine collection during polysomnography, collection periods are: 2:00 p.m. to 5:00 p.m., 5:00 p.m. to 8:00 p.m., 8:00 p.m. to 8:00 a.m., 8:00 a.m. to 11:00 a.m., 11:00 a.m. to 2:00 p.m.

Treatment groups

760 Participants
are divided into 3 treatment groups
Group A: General populationExperimental treatment 1 intervention
Group B: Patients with wakeness disordersActive comparator 7 interventions
Group C: Healthy volunteersExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Internal consistency of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A)

The ESEA is a self-assessment questionnaire adapted from the Epworth Sleepiness Scale. It evaluates daytime sleepiness in common daily situations. Scores range from 0 to 30. Internal consistency will be assessed using Cronbach's alpha. The analysis will be performed separately for: * ESEA-E (children aged 6-11 years) * ESEA-A (adolescents aged 12-17 years) Each Cronbach's alpha coefficient will be reported independently for each scale version.

Time frame
Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
2

Internal consistency of the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A)

IHSS : A self-administered 14-item questionnaire assessing hypersomnolence, evaluating excessive sleepiness, daytime fatigue, and difficulty maintaining wakefulness, as well as their impact on academic, social, and daily functioning. Internal consistency will be assessed using Cronbach's alpha. The analysis will be performed separately for: IHSS-E (children aged 6-11 years) IHSS-A (adolescents aged 12-17 years). Each Cronbach's alpha coefficient will be reported independently for each scale version.

Time frame
Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
3

Internal consistency of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11 years)

PDSS (6-11) is an 8-item self-administered questionnaire adapted from the PDSS for older children. It measures daytime sleepiness and its impact on daily functioning, especially at school, based on the frequency of fatigue and sleep episodes. Scores range from 0 to 32. Internal consistency will be assessed using Cronbach's alpha.

Time frame
Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
4

Internal consistency of the French Sleepiness Scale for children (FSSC-8)

FSSC-8 an 8-item self-administered questionnaire adapted from the validated adolescent version (FSSA-8) to assess daytime sleepiness in children. It evaluates the frequency of sleepiness episodes in daily situations. Scores range from 0 to 24.Internal consistency will be assessed using Cronbach's alpha.

Time frame
Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

Secondary outcomes

1

Correlation coefficients between the Idiopathic Hypersomnia Severity Scale for children and adolescents (IHSS-A and IHSS-E ) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17years).

IHSS : A self-administered 14-item questionnaire assessing hypersomnolence, evaluating excessive sleepiness, daytime fatigue, and difficulty maintaining wakefulness, as well as their impact on academic, social, and daily functioning. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated PDSS is an 8-item self-administered questionnaire adapted from the PDSS for older children. It measures daytime sleepiness and its impact on daily functioning, especially at school, based on the frequency of fatigue and sleep episodes. Scores range from 0 to 32

Time frame
Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
2

Correlation coefficients between the Idiopatic Hypersomnia Severity Scale (IHSS-A and IHSS-E ) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD).

IHSS : A self-administered 14-item questionnaire assessing hypersomnolence, evaluating excessive sleepiness, daytime fatigue, and difficulty maintaining wakefulness, as well as their impact on academic, social, and daily functioning. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.

Time frame
Baseline (V1) and during the hospitalization visit at 2 months
3

Correlation coefficients between the Pediatric Hypersomnolence Scale (PHS; 6-11 and 12-17 years) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17 years)

PDSS is an 8-item self-administered questionnaire adapted from the PDSS for older children. It measures daytime sleepiness and its impact on daily functioning, especially at school, based on the frequency of fatigue and sleep episodes. Scores range from 0 to 32. PHS is a 14-item self-report questionnaire assessing excessive daytime sleepiness in adolescents (12-17), in relation to school and social activities. Scores range from 0 to 42, with a pathological threshold \>24 for narcolepsy/hypersomnia. A French version for children aged 6-11 (PHS 6-11) is awaiting validation.

Time frame
Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
4

Correlation coefficients between the Pediatric Hypersomnolence Scale for children and adolescents (PHS; 6-11 and 12-17 years) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)

PHS is a 14-item self-report questionnaire assessing excessive daytime sleepiness in adolescents (12-17), in relation to school and social activities. Scores range from 0 to 42, with a pathological threshold \>24 for narcolepsy/hypersomnia. A French version for children aged 6-11 (PHS 6-11) is awaiting validation. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.

Time frame
Baseline (V1) and during the hospitalization visit at 2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Société Française de Recherche et de Médecine du Sommeil

Collaborator

Source ClinicalTrials.gov

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